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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02506751 |
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Date of registration:
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12/07/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Open-label Study of Liothyronine in MS
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Scientific title:
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A Phase 1b, Open-label Study to Evaluate the Safety and Tolerability of the Putative Remyelinating Agent, Liothyronine, in Individuals With MS |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02506751 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Scott Newsome, DO |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johns Hopkins University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Must meet 2010 McDonald criteria for clinically definite MS
- Must be euthyroid
- Expanded Disability Status Scale (EDSS) 3.0-7.5
- Patients may be on MS immunomodulating therapies or immunosuppressant therapies during
the study
Exclusion Criteria:
- Known thyroid disease (past or current)
- Currently on thyroid replacement therapy
- Steroid use within a month of screening
- History of coronary artery disease, atrial fibrillation, or other clinically
significant cardiac disease
- History of adrenal insufficiency
- Ongoing renal and/or liver disease
- Ongoing severe depression and/or anxiety
- Use of carbamazepine, phenytoin, phenobarbital, warfarin, antacids, cholestyramine,
colestipol, sucralfate, and rifampin
- Known contraindication to using beta-blocker medications
- History of alcohol or substance abuse in the past 6 months
- Pregnant or nursing
- If the investigator feels that participation in this study is not in the best interest
of the subject
Age minimum:
18 Years
Age maximum:
58 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis, Relapsing-Remitting
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Multiple Sclerosis, Secondary Progressive
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Multiple Sclerosis, Primary Progressive
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Intervention(s)
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Drug: liothyronine
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Primary Outcome(s)
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The incidence rate of adverse events
[Time Frame: 26 weeks]
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Secondary ID(s)
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IRB00061965
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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